The following data is part of a premarket notification filed by Noris Medical Ltd. with the FDA for Noris Medical Dental Implants System.
| Device ID | K140440 |
| 510k Number | K140440 |
| Device Name: | NORIS MEDICAL DENTAL IMPLANTS SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | NORIS MEDICAL LTD. 8 HATAASIA Nesher, IL 3688808 |
| Contact | Raanan Aloni |
| Correspondent | Raanan Aloni NORIS MEDICAL LTD. 8 HATAASIA Nesher, IL 3688808 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-21 |
| Decision Date | 2014-12-19 |
| Summary: | summary |